Blood sampling transfer device

ABSTRACT

A blood sampling transfer device that includes a lancing tape having a flow channel and a transfer cartridge removably connected to the lancing tape is disclosed. The blood sampling transfer device provides a closed system that reduces the exposure of a blood sample to both skin and environment and provides fast mixing of a blood sample with a sample stabilizer.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims priority to U.S. Provisional ApplicationNo. 61/811,918, filed Apr. 15, 2013, entitled “Medical Device forCollection of a Biological Sample”, the entire disclosure of which ishereby incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Disclosure

The present disclosure relates generally to devices, assemblies, andsystems adapted for use with vascular access devices and capillary bloodaccess devices. More particularly, the present disclosure relates todevices, assemblies, and systems adapted for collecting biologicalsamples for use in point-of-care testing.

2. Description of the Related Art

Blood sampling is a common health care procedure involving thewithdrawal of at least a drop of blood from a patient. Blood samples arecommonly taken from hospitalized, homecare, and emergency room patientseither by finger stick, heel stick, or venipuncture. Blood samples mayalso be taken from patients by venous or arterial lines. Once collected,blood samples may be analyzed to obtain medically useful informationincluding, for example, chemical composition, hematology, andcoagulation.

Blood tests determine the physiological and biochemical states of thepatient, such as disease, mineral content, drug effectiveness, and organfunction. Blood tests may be performed in a clinical laboratory or atthe point-of-care near the patient. One example of point-of-care bloodtesting is the routine testing of a patient's blood glucose levels whichinvolves the extraction of blood via a finger stick and the mechanicalcollection of blood into a diagnostic strip or cartridge. Thereafter,the diagnostic cartridge, often using an associated instrument intowhich the strip or cartridge is inserted, analyzes the blood sample andprovides the clinician a reading of the patient's blood glucose level.Other devices are available which analyze blood gas electrolyte levels,lithium levels, and ionized calcium levels. Some other point-of-caredevices identify markers for acute coronary syndrome (ACS) and deep veinthrombosis/pulmonary embolism (DVT/PE).

Despite the rapid advancement in point-of-care testing and diagnostics,blood sampling techniques have remained relatively unchanged. Bloodsamples are frequently drawn using hypodermic needles or vacuum tubesattached to a proximal end of a needle or a catheter assembly. In someinstances, clinicians collect blood from an already inserted vascularlylocated catheter assembly using a needle and syringe that is insertedinto the catheter to withdraw blood from a patient through the insertedcatheter. These procedures utilize needles and vacuum tubes asintermediate devices from which the collected blood sample is typicallywithdrawn prior to testing. These processes are thus device intensive,utilizing multiple devices in the process of obtaining, preparing, andtesting blood samples. Each additional device increases the time andcost of the testing process.

Point-of-care testing devices allow for a blood sample to be testedwithout needing to send the blood sample to a lab for analysis. Thus, itis desirable to create a device that provides an easy, safe,reproducible, and accurate process with a point-of-care testing system.

SUMMARY OF THE INVENTION

The present disclosure provides a biological fluid sampling transferdevice, such as a blood sampling transfer device, that includes alancing tape having a flow channel and a transfer cartridge removablyconnected to the lancing tape. The blood sampling transfer deviceprovides a closed system that reduces the exposure of a blood sample toboth skin and environment and provides fast mixing of a blood samplewith a sample stabilizer. The sample stabilizer, can be ananticoagulant, or a substance designed to preserve a specific elementwithin the blood such as, for example, RNA, protein analyte, or otherelement.

In accordance with an embodiment of the present invention, a bloodsampling transfer device includes a lancing tape having a flow channeland a transfer cartridge removably connected to the lancing tape, thetransfer cartridge having a reservoir, wherein with the transfercartridge connected to the lancing tape, the reservoir is in fluidcommunication with the flow channel, and wherein with the transfercartridge disconnected from the lancing tape, the reservoir is sealed.

In one configuration, the lancing tape includes a target for a lancetdevice. In another configuration, the target of the lancing tape isaligned with the flow channel. In yet another configuration, the targetof the lancing tape is a circular graphic indicator. In oneconfiguration, the transfer cartridge includes a transfer cartridge flowchannel in fluid communication with the reservoir. In anotherconfiguration, the transfer cartridge flow channel contains a samplestabilizer. In yet another configuration, the transfer cartridgeincludes a dispensing bulb in fluid communication with the transfercartridge flow channel, the transfer cartridge flow channel beingdisposed between the dispensing bulb and the reservoir. In oneconfiguration, the blood sampling transfer device includes a frangibleportion between the transfer cartridge and the lancing tape, wherein thetransfer cartridge is removably connected to the lancing tape via thefrangible portion.

In accordance with another embodiment of the present invention, a bloodsampling system includes a lancet device having a puncturing element;and a blood sampling transfer device including a lancing tape having aflow channel and a target aligned with the flow channel, the target forthe puncturing element of the lancet device, and a transfer cartridgeremovably connected to the lancing tape, the transfer cartridge having areservoir, wherein with the transfer cartridge connected to the lancingtape, the reservoir is in fluid communication with the flow channel, andwherein with the transfer cartridge disconnected from the lancing tape,the reservoir is sealed.

In one configuration, the target of the lancing tape is a circulargraphic indicator. In another configuration, the transfer cartridgeincludes a transfer cartridge flow channel in fluid communication withthe reservoir. In yet another configuration, the transfer cartridge flowchannel contains a sample stabilizer. In one configuration, the transfercartridge includes a dispensing bulb in fluid communication with thetransfer cartridge flow channel, the transfer cartridge flow channelbeing disposed between the dispensing bulb and the reservoir. In anotherconfiguration, the blood sampling system includes a frangible portionbetween the transfer cartridge and the lancing tape, wherein thetransfer cartridge is removably connected to the lancing tape via thefrangible portion.

In accordance with another embodiment of the present invention, abiological fluid sampling system, such as a blood sampling system,includes a lancet device having a puncturing element; a blood samplingtransfer device including a lancing tape having a flow channel and atarget aligned with the flow channel, the target for the puncturingelement of the lancet device, and a transfer cartridge removablyconnected to the lancing tape, the transfer cartridge having areservoir, wherein with the transfer cartridge connected to the lancingtape, the reservoir is in fluid communication with the flow channel, andwherein with the transfer cartridge disconnected from the lancing tape,the reservoir is sealed; and a packaging member having a compartmentsized and adapted to receive the lancet device and the blood samplingtransfer device therein.

In one configuration, the packaging member includes a blister package.In another configuration, the lancing tape includes an adhesive on aninferior surface of the lancing tape.

In accordance with another embodiment of the present invention, abiological fluid separation system, such as a blood separation system,for a blood sample having a cellular portion and a plasma portionincludes a blood sampling transfer device adapted to receive the bloodsample, the blood sampling transfer device including a lancing tapehaving a flow channel and a transfer cartridge removably connected tothe lancing tape, the transfer cartridge having a reservoir, whereinwith the transfer cartridge connected to the lancing tape, the reservoiris in fluid communication with the flow channel, and wherein with thetransfer cartridge disconnected from the lancing tape, the reservoir issealed; and a centrifuge having a receiving port adapted to receive thetransfer cartridge, wherein with the transfer cartridge received withinthe centrifuge and a rotational force applied to the transfer cartridge,the plasma portion of the blood sample is separated from the cellularportion through the reservoir.

In one configuration, the lancing tape includes an adhesive on aninferior surface of the lancing tape.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of a blood sampling transfer device inaccordance with an embodiment of the present invention.

FIG. 2 is an elevation view of a blood sampling transfer device inaccordance with an embodiment of the present invention.

FIG. 3 is a perspective view of a blood sampling transfer device with atransfer cartridge being bent at a frangible portion in accordance withan embodiment of the present invention.

FIG. 4 is a cross-sectional view of a blood sampling transfer devicetaken along line 4-4 of FIG. 1 in accordance with an embodiment of thepresent invention.

FIG. 5 is a perspective view of a blood sampling transfer device with atransfer cartridge removed from a lancing tape in accordance with anembodiment of the present invention.

FIG. 6 is a cross-sectional view of the transfer cartridge of FIG. 5 inaccordance with an embodiment of the present invention.

FIG. 7 is a perspective view of a lancet device in accordance with anembodiment of the present invention.

FIG. 8 is an exploded, perspective view of a lancet device in accordancewith an embodiment of the present invention.

FIG. 9 is a cross-sectional view of the lancet device of FIG. 8 inaccordance with an embodiment of the present invention.

FIG. 10 is an elevation view of a blood sampling system in accordancewith an embodiment of the present invention.

FIG. 11 is a perspective view of a blood sampling transfer device with alancing tape secured to a patient in accordance with an embodiment ofthe present invention.

FIG. 12 is a perspective view of a blood sampling transfer device with alancing tape secured to a patient and a lancet device aligned with thelancing tape in accordance with an embodiment of the present invention.

FIG. 13 is a cross-sectional view of the lancet device and the lancingtape secured to a patient in accordance with an embodiment of thepresent invention.

FIG. 14 is a cross-sectional view of the transfer cartridge of FIG. 5 inaccordance with an embodiment of the present invention.

FIG. 15 is a perspective view of a blood separation system in accordancewith an embodiment of the present invention.

FIG. 16 is a cross-sectional view of the transfer cartridge of FIG. 5 inaccordance with an embodiment of the present invention.

FIG. 17 is a perspective view of a transfer cartridge and apoint-of-care testing device in accordance with an embodiment of thepresent invention.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary embodiments of the disclosure, and suchexemplifications are not to be construed as limiting the scope of thedisclosure in any manner.

DETAILED DESCRIPTION

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention.

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume alternative variations and step sequences,except where expressly specified to the contrary. It is also to beunderstood that the specific devices and processes illustrated in theattached drawings, and described in the following specification, aresimply exemplary embodiments of the invention. Hence, specificdimensions and other physical characteristics related to the embodimentsdisclosed herein are not to be considered as limiting.

Various point-of-care testing devices are known in the art. Suchpoint-of-care testing devices include test strips, glass slides,diagnostic cartridges, or other testing devices for testing andanalysis. Test strips, glass slides, and diagnostic cartridges arepoint-of-care testing devices that receive a blood sample and test thatblood for one or more physiological and biochemical states. There aremany point-of-care devices that use cartridge based architecture toanalyze very small amounts of blood at the point of care without theneed to send the sample to a lab for analysis. This saves time ingetting results over the long run but creates a different set ofchallenges versus the highly routine lab environment. Examples of suchtesting cartridges include the i-STAT® testing cartridge from the Abbotgroup of companies. Testing cartridges such as the i-STAT® cartridgesmay be used to test for a variety of conditions including the presenceof chemicals and electrolytes, hematology, blood gas concentrations,coagulation, or cardiac markers. The results of tests using suchcartridges are quickly provided to the clinician.

However, the samples provided to such point-of-care testing cartridgesare currently manually collected with an open system and transferred tothe point-of-care testing cartridge in a manual manner that often leadsto inconsistent results, or failure of the cartridge leading to a repeatof the sample collection and testing process, thereby negating theadvantage of the point-of-care testing device. Accordingly, a needexists for a system for collecting and transferring a sample to apoint-of-care testing device that provides safer, reproducible, and moreaccurate results. Accordingly, a point-of-care collecting andtransferring system of the present disclosure will be describedhereinafter. A system of the present disclosure enhances the reliabilityof the point-of-care testing device by: 1) incorporating a more closedtype of sampling and transfer system; 2) minimizing open exposure of thesample; 3) improving sample quality; 4) improving the overall ease ofuse; and 5) separating the sample at the point of collection.

FIGS. 1-6 illustrate an exemplary embodiment of the present disclosure.Referring to FIGS. 1-6, a biological fluid sampling transfer device,such as a blood sampling transfer device 10 of the present disclosure,includes a lancing tape 12 having a flow channel 48 and a transfercartridge 14 removably connected to the lancing tape 12. The bloodsampling transfer device 10 of the present disclosure provides a closedsystem that reduces the exposure of a blood sample and provides fastmixing of a blood sample with a sample stabilizer.

FIG. 10 illustrates an exemplary embodiment of the present disclosure.Referring to FIG. 10, a biological fluid sampling system, such as ablood sampling system 20 of the present disclosure, includes a kit 22having a lancet device 24, a blood sampling transfer device 10 having alancing tape 12 having a flow channel 48 and a transfer cartridge 14removably connected to the lancing tape 12, and a packaging member 26having a compartment 68 sized and adapted to receive the lancet device24 and the blood sampling transfer device 10 therein.

FIG. 15 illustrates an exemplary embodiment of the present disclosure.Referring to FIG. 15, a blood separation system 30 of the presentdisclosure for a blood sample includes a blood sampling transfer device10 adapted to receive a blood sample and having a lancing tape 12 havinga flow channel 48 and a transfer cartridge 14 removably connected to thelancing tape 12, and a centrifuge 32 having a receiving port 74 adaptedto receive the transfer cartridge 14 such that with the transfercartridge 14 received within the centrifuge 32 and a rotational forceapplied to the transfer cartridge 14, a plasma portion of the bloodsample is separated from a cellular portion.

Referring to FIGS. 1-5, lancing tape 12 generally includes alongitudinal portion 40, a radial portion 42 extending from thelongitudinal portion 40, a target or graphic indicator 44 on the radialportion 42, an inlet port 46 in fluid communication with the target 44,a lancing tape flow channel 48 integrally formed within the lancing tape12 and in fluid communication with the inlet port 46, and an exit port50 in fluid communication with the lancing tape flow channel 48 and aportion of the transfer cartridge 14 as will be described below.Referring to FIG. 1, the lancing tape 12 also includes a superiorsurface 45 and an inferior surface 47. The inferior surface 47 includesa mechanism for removably adhering the lancing tape 12 to a patient asshown in FIGS. 11 and 12.

In one embodiment, the inferior surface 47 includes an adhesive. Theinferior surface 47 includes an adhesive so that the lancing tape 12 canbe secured onto a skin surface S of a patient where a blood sample willbe accessed. In one embodiment, the adhesive of the inferior surface 47is protected by a peel-off layer, similar to an adhesive bandage, whichwould be removed before placing the lancing tape 12 on the skin surfaceS of the patient's body. A hydrogel or other layer (not shown) could beincluded to provide some thickness to the inferior surface 47 of thelancing tape 12 and help improve the stability of the adhesive seal.Additionally, in one embodiment, the adhesive could include a chemistryto create a more liquid-tight seal, similar to painter's tapetechnology, where wetting from the paint itself causes a chemicalreaction with the adhesive to create a more water-tight barrier toprevent the paint from seeping under the tape. Importantly, the adhesiveprovides for proper adhesion of the lancing tape 12 to the skin surfaceS of a patient and minimizes skin contact which leads to a better samplefor coagulation testing. The adhesive of the lancing tape 12 can bepunctured by the lancet device 24 such that the blood evolving from thewound beneath passes through the cut into the lancing tape 12 to becollected inside the blood sampling transfer device 10. In oneembodiment, the lancing tape 12 includes two layers, a bottom portionhaving an adhesive layer that is in contact with the skin and an upperportion that receives the evolving blood. The adhesive of the presentdisclosure includes an anti-leak mechanism. For example, in oneembodiment, a self-sealing or self-healing polymer is used. In anotherembodiment, the top portion of the lancing tape 12 comprises adome-shaped blister, which compresses under the lancet, but which popsback to its original shape after a lancing action thereby creating aspace into which the blood will evolve, and then get wicked or moved bycapillary action into the rest of the blood sampling transfer device 10.In another embodiment, the popping back to its original shape of thedome-shaped blister allows a vacuum force that helps pull the blood outof the wound.

The target 44 of the lancing tape 12 provides an alignment and targetingmechanism for the lancet device 24 as shown in FIG. 12. In oneembodiment, the target 44 comprises a circular shape. In otherembodiments, the target 44 can have other multi-sided polygoncross-sectional shapes, such as square or rectangular cross-sectionalshapes. As shown in FIGS. 1 and 2, the target 44 of the lancing tape 12is aligned with and in fluid communication with the inlet port 46 andthe lancing tape flow channel 48.

Referring to FIGS. 1-6, transfer cartridge 14 generally includes aninlet port 52 in fluid communication with the exit port 50 of thelancing tape 12, an entry reservoir 56 in fluid communication with theinlet port 52, a transfer cartridge flow channel 58 in fluidcommunication with the entry reservoir 56, an exit reservoir ordispensing bulb 60 in fluid communication with the transfer cartridgeflow channel 58, an exit port 54 in fluid communication with the exitreservoir 60, a valve 62 disposed in communication with the exit port54, and an end cap 64. The transfer cartridge 14 is adapted to contain asample stabilizer to provide passive and fast mixing of a blood samplewith the sample stabilizer. The sample stabilizer can be ananticoagulant, or a substance designed to preserve a specific elementwithin the blood such as, for example, RNA, protein analyte, or otherelement. In one embodiment, the sample stabilizer is provided within thetransfer cartridge flow channel 58. In other embodiments, the samplestabilizer is provided in other areas of the transfer cartridge 14 suchas the inlet port 52 or the entry reservoir 56.

In one embodiment, the transfer cartridge flow channel 58 comprises aserpentine shape to promote efficient mixing of a blood sample 34 (FIGS.14 and 16) having a cellular portion 36 and a plasma portion 38. Asdiscussed below, a centrifuge 32 provides a rotational force applied tothe transfer cartridge 14 to separate the plasma portion 38 from thecellular portion 36 through the transfer cartridge flow channel 58. Inother embodiments, the transfer cartridge flow channel 58 comprisesother shapes to promote efficient mixing of a blood sample.

The valve 62 is transitionable between a closed position to seal aplasma portion within the exit reservoir 60 of the transfer cartridgeand an open position to allow a plasma portion to flow through the exitport 54 and the end cap 64 to a point-of-care testing device 90 as shownin FIG. 17.

Referring to FIGS. 1-5, the transfer cartridge 14 is removably connectedto the lancing tape 12 via a frangible element or frangible portion 16.With the transfer cartridge 14 connected to the lancing tape 12, theentry reservoir 56 and inlet port 52 of the transfer cartridge 14 are influid communication with the lancing tape flow channel 48 and exit port50 of the lancing tape 12. The frangible element 16 includes a frangibleelement sealing wall 66. Referring to FIG. 5, after the frangibleelement 16 is broken to remove the transfer cartridge 14 from thelancing tape 12, the frangible element sealing wall 66 seals the inletport 52 of the transfer cartridge 14. After the frangible element 16 isbroken to remove the transfer cartridge 14 from the lancing tape 12, theexit port 50 of the lancing tape 12 is also sealed to seal the lancingtape flow channel 48.

Referring to FIG. 10, a blood sampling system 20 of the presentdisclosure includes a kit 22 having a lancet device 24, a blood samplingtransfer device 10 having a lancing tape 12 having a flow channel 48 anda transfer cartridge 14 removably connected to the lancing tape 12, anda packaging member 26 having a compartment 68 sized and adapted toreceive the lancet device 24 and the blood sampling transfer device 10therein. The packaging member 26 includes a body or wall defining acompartment 68. In one embodiment, the body of the packaging member 26defines a first compartment 70 sized and adapted to receive the bloodsampling transfer device 10 therein and a second compartment 72 sizedand adapted to receive the lancet device 24 therein. In one embodiment,the packaging member 26 comprises a blister package. In one embodiment,a sealing cover is secured over the packaging member 26 to seal theblood and sampling transfer device 10 and the lancet device 24 therein,i.e., the sealing cover provides a substantially impermeable enclosurewith respect to packaging member 26, provides a leak prevention andprotection enclosure, protects the contents of the blood and samplingtransfer device 10 and the lancet device 24 contained within packagingmember 26, and/or maintains a sealed, sterilized environment withinpackaging member 26. The sealing cover of the packaging member 26provides a sufficient seal at a range of temperatures, pressures, andhumidity levels. In one embodiment, tamper evidence is also provided byuse of a tear strip or other indicating means secured to a portion ofthe sealing cover and/or packaging member 26 to indicate tampering withthe contents of packaging member 26.

Referring to FIGS. 7, 8, 9, 12, and 13, a lancet device 24 of thepresent disclosure is shown. In one embodiment, the lancet device 24 maybe a contact activated lancet device. In other embodiments, the lancetdevice 24 may be any type of lancet device. In another embodiment, thelancet device 24 may be sized to be contained within a target 44 or domeof the lancing tape 12. In this manner, a user could push down on thetarget 44 to activate the lancet and pierce the skin of a patient.

In one embodiment, the lancet device 24 generally includes a housing100, a shield 102 movably associated with the housing 100, and a lancetstructure 104 disposed therein. As will be discussed below, the shield102 is coaxially and movably associated with the housing 100, and ispartially disposed within the housing 100, extending partially outwardfrom the housing 100, with the lancet structure 104 contained within andaxially or longitudinally movable through the shield 102. The lancetstructure 104 includes a puncturing element 106, the lancet structure104 at least partially disposed within the housing 100 and adapted formovement between a pre-actuated position (FIG. 9) wherein the puncturingelement 106 is retained within the housing 100 and a puncturing position(FIG. 13) wherein at least a portion of the puncturing element 106extends through a forward end 110 of the housing 100.

The housing 100 defines an elongated body, and is desirably formed witha main body 112 defining a distal or forward end 110, and a rear cap 114defining a proximal or rearward end 116. The interior portion of housing100 is generally open defining an internal cavity 118, the internalcavity 118 is closed at the rearward end 116 through rear cap 114 andincludes an opening 120 through the forward end 110, through which theshield 102 extends. Main body 112 and rear cap 114 may be integrallyformed. Alternatively, main body 112 and rear cap 114 are separateelements which are affixed to each other to form housing 100, which aidsin assembly of the lancet device 24. Main body 112 and rear cap 114 maybe affixed together through an appropriate adhesive, or may includeinter-engaging structure providing a mechanical attachment therebetween,such as a frictional fit or a snap fit construction. In an alternateembodiment, main body 112 and rear cap 114 may be an integrally formedstructure, and may therefore be molded together as one component.

As shown in FIGS. 7 and 8, the housing 100, defined by main body 112 andrear cap 114, has opposed sides 121, 122, which may each include asurface for accommodating a user's fingers, such as finger gripindentations 123, which may be formed as a concave depression or recess.While two opposed finger grip indentations 123 may be provided on thehousing 100, it will be appreciated that only one finger gripindentation 123 formed in the housing 100 may be provided in accordancewith the present invention. Additionally, the rearward end 116 ofhousing 100, such as the top surface of rear cap 114, may also include asurface for accommodating a user's finger, such as a rear finger gripindentation 124, which may also be formed as a concave depression orrecess. The side finger grip indentations 123 and the rear finger gripindentation 124 provide ergonomically shaped surfaces that substantiallyconform to a user's fingertips to aid the user in manipulating thelancet device 24 and using the lancet device 24 in a blood letting,drawing, or collection procedure, and may provide multiple finger grippositions for the user. In one embodiment, the housing 100 may furtherinclude structure to generally improve the grip between the housing 100and the user's fingertips, such as a plurality of longitudinal ribs 125and troughs 126 extending along the housing 100 and integrally formedwith the housing 100, which may provide a visual and tactile cue to theuser to instruct the user where to place his or her fingertips.

The shield 102 extends outward from the opening 120 through the forwardend 110 of the housing 100. As shown in FIGS. 9 and 13, the shield 102is a generally cylindrical hollow structure having a shield body 130extending between a forward end 132 and a rearward end 134, and definingan internal cavity 136 extending therethrough. The forward end 132 ofthe shield body 130 defines a forward end wall 138 including a forwardopening 140 therethrough, through which the puncturing element 106 ofthe lancet structure 104 extends when the lancet device 24 is actuatedby the user. The forward end wall 138 generally defines a small contactarea about the opening 140 for contacting the intended area on theuser's body which is to be punctured by the puncturing element. Theshield 102 is axially or longitudinally movable within the housing 100.The shield 102 and housing 100 may include corresponding guidingsurfaces for guiding the shield 102 through the housing 100.

Lancet device 24 further includes a lancet structure 104 disposed withinthe housing 100, and extending through shield 102. As shown in FIGS. 9and 13, lancet structure 104 includes a puncturing element 106, shown inthe form of lancet 108 defining a puncturing end 109 at the forward endthereof. Lancet structure 104 is adapted for axial or longitudinalmovement through the internal cavity 136 of the shield body 130 betweenan initial armed or pre-actuated position with the puncturing end 109maintained within the shield body 130 to a puncturing position in whichthe puncturing end 109 extends beyond the forward opening 140 of shieldbody 130. Puncturing end 109 is adapted for puncturing the skin of apatient, and may define a pointed end, a blade edge, and the like.Puncturing end 109 may include a preferred alignment orientation, suchas with a pointed end of a blade aligned in a specific orientation.

As shown in FIGS. 9 and 13, a retaining hub 150 is provided at therearward end 134 of the shield body 130. Retaining hub 150 is providedas a separate structure disposed or retained within the rearward end 134of shield body 130. In one embodiment, shield body 130 may include asurface for supporting and positioning retaining hub 150 to assist inassembly. In another embodiment, the retaining hub 150 may be molded orformed directly onto the shield body 130.

Retaining hub 150 defines a lever structure 152 for retaining the lancetstructure 104 in an initial armed position retracted within housing 100as shown in FIG. 9. Retaining hub 150 and lancet structure 104 are ininterference engagement with each other, such that retaining hub 150retains the lancet structure 104 in an initial armed position retractedwithin housing 100.

Moreover, the lever element 152 is adapted for contacting engagementwith a structure defined within housing 100. For example, rear cap 114of housing 100 may include structure extending therein, such as aninternal contact 128 integrally formed and extending on at least one,and desirably on two opposing inner sidewalls thereof as shown in FIGS.9 and 13. Each internal contact 128 includes an engagement surface 129for contacting engagement with a contact surface of lever element 152,forming a cam surface. In this manner, the pair of internal contacts 128may engage the lever elements 152, thereby providing a continualcam-like contact surface during pivotal movement of lever element 152.

Movement of the lancet structure 104 through the lancet device 24 isachieved through a biasing force provided through a drive spring 160.Drive spring 160 is adapted to exert a biasing force against lancetstructure 104 to drive lancet structure 104 through the device towardthe puncturing position, and may be disposed between the rearward end ofthe housing 100 and the lancet structure 104. When the lancet structure104 is in an armed position, the drive spring 160 exerts a force againstthe lancet structure, such as between the rearward end of housing 100and the lancet structure 104, biasing the lancet structure 104 towardthe puncturing position.

Referring to FIGS. 9 and 13, a retraction spring 162 may be provided atthe forward end of the lancet device 24, for retracting the lancetstructure 104 within the shield body 130 after the lancet structure 104is axially moved to the puncturing position. The retraction spring 162extends between a forward surface of the lancet structure 104 and aninner surface within the forward end wall 138 of the shield body 130.Retraction spring 162 is typically a compression spring, capable ofstoring energy when in a compressed state.

Referring to FIGS. 7 and 8, lancet device 24 may further include aprotective cover 170 for protectively covering the lancet device 24prior to use thereof. The protective cover 170 may include a tab member172 associated with the forward end of the lancet device 24, whichmaintains sterility of the forward end wall 138 of shield body 130. Thetab member 172 may include a forward tab portion 174 and a dependingskirt 176. The depending skirt 176 is adapted to cooperate with theforward end 132 of the shield body 130, generally encompassing orenclosing the forward end 132. The depending skirt 176 also contacts theforward end 110 of the main body 112 of the housing 100. In this manner,the tab member 172 encloses forward opening 120 of main body 112 andforward opening 140 of shield body 130. Moreover, such arrangementmaintains the respective forward ends of main body 112 and shield body130 in fixed relation with respect to each other, thereby preventingmovement therebetween which could cause premature activation of thelancet device 24. In one embodiment, a post portion 178 of theprotective cover 170 may extend within the shield body 130 to encompassat least a portion of the puncturing element 106.

The respective elements of the lancet device of the present inventionare all typically formed of molded plastic material, such as a medicalgrade plastic material. The lancet 108 may be constructed of anysuitable material adapted for puncturing the skin, and is typically asurgical grade metal such as stainless steel.

Referring to FIGS. 7-9 and 13, use of the lancet device 24 will now bedescribed. To prepare the lancet assembly for use, the user grasps thehousing 100, such as between a finger and thumb on opposing sides 121,122, and removes the protective cover 170 from the forward end as shownin FIG. 8, thereby exposing the shield body 130 extending from theforward end of main body 112 of housing 100. The forward end wall 138 ofshield body 130 may then be contacted with a location on the user's bodyor another person's body where it is desired to initiate blood flow,such as the patient's skin surface S as shown in FIGS. 11-13.

Once placed against the body, the user exerts a downwardly directedforce on the housing 100 forcing shield body 130 against skin surface S.Since retaining hub 150 is adjacent rearward end 134 of shield body 130,such displacement of the shield body 130 toward the rear cap 114 causescorresponding rearward movement of retaining hub 150 toward rear cap114. Such movement causes drive spring 160 to compress. This compressingof drive spring 160 arms drive spring 160 with a biasing forcesufficient to propel lancet structure 104 axially forward through shieldbody 130 to the puncturing position, thereby providing lancet structure104 in an armed position. At this point, however, lancet structure 104is still maintained such that puncturing end 109 is retracted withinshield body 130 due to the interference engagement between the retaininghub 150 and the lancet structure 104.

Such rearward movement of retaining hub 150 causes the cam surfaces ofengagement surfaces 129 of the internal contacts 128 within rear cap 114to engage and co-act with the corresponding contact surfaces of thelever elements 152. Accordingly, the corresponding camming contactsurfaces provide an actuator element for the lancet device 24. Suchengagement and co-action causes the lever elements 152 to pivot torelease the lancet structure 104 through the shield body 130.Eventually, such pivoting causes the lever elements 152 to be pivoted toa point at which the interference engagement between the retaining hub150 and the lancet structure 104 is released, as shown in FIG. 13. Thebiasing force of drive spring 160 propels lancet structure 104 downwardaway from the rear cap 114 axially through housing 100 and shield body130.

Referring to FIG. 15, a blood separation system 30 of the presentdisclosure for a blood sample 34 (FIGS. 14 and 16) having a cellularportion 36 and a plasma portion 38 includes a blood sampling transferdevice 10 adapted to receive a blood sample and having a lancing tape 12having a flow channel 48 and a transfer cartridge 14 removably connectedto the lancing tape 12, and a centrifuge 32 having a receiving port 74adapted to receive the transfer cartridge 14 such that with the transfercartridge 14 received within the centrifuge 32 and a rotational forceapplied to the transfer cartridge 14, a plasma portion of the bloodsample is separated from a cellular portion. The centrifuge 32 includesa plurality of receiving ports 74 adapted to receive a transfercartridge 14, a base or bottom portion 78, a top portion 76 movablyconnected to the base portion 78 by a hinged portion 80, and arotational force element 82 contained within the base portion 78. Thetop portion 76 is transitionable between an open position in which atransfer cartridge 14 can be placed within a receiving port 74 as shownin FIG. 15 and a closed position. With the transfer cartridge 14received within the centrifuge 32, a rotational force is applied to thetransfer cartridge 14 to separate the plasma portion 38 from thecellular portion 36 as described in more detail below.

Referring to FIGS. 10-17, use of a blood sampling transfer device of thepresent disclosure will now be described. Referring to FIGS. 10-12, uponselecting a site, a clinician removes the lancing tape 12 with thetransfer cartridge 14 connected thereto from the packaging member 26.The clinician then adheres the lancing tape 12 over a selected samplingsite as shown in FIGS. 11 and 12. A target for a lancet device 24 ishighlighted with the target 44 provided on the lancing tape 12. Theclinician then places a tip of the lancet device 24 onto the target 44and pushes against the site in the direction of arrow A to activate thelancet device 24 and puncture the skin S. The target 44 corresponds tothe integrated flow through channel 48 to carry blood through thelancing tape flow channel 48 of the lancing tape 12 and into the entryreservoir 56 of the transfer cartridge 14 via capillary action. Thetransfer cartridge 14 contains anti-coagulant within a serpentine (orother) flow channel 58 to promote efficient mixing of specimen. When theentry reservoir 56 of the transfer cartridge 14 is filled, the cliniciancan snap off the frangible element 16 between the lancing tape 12 andthe transfer cartridge 14. When broken away, the flow channel 58 of thetransfer cartridge 14 is sealed from the external environment.

Referring to FIG. 15, the next step of the process involves manualinsertion into a point-of-care centrifuge device 32 designedspecifically for the transfer cartridge 14. The blood is quickly spunand due to the low volume is separated within a few seconds such thatthe plasma portion 38 is collected within a dispensing bulb 60 of thetransfer cartridge 14. The transfer cartridge 14 is removed manuallyfrom the centrifuge device 32. Thereafter, referring to FIG. 17, theplasma portion of the blood sample within the dispensing bulb 60 of thetransfer cartridge 14 is dispensed through the exit port 54 of thetransfer cartridge 14 by squeezing the dispensing bulb 60 into a well orreceiving port 92 of the point-of-care testing device 90 to perform thedesired test. The dispensing bulb 60 has a valve 62 to avoid leakinguntil the bulb 60 is depressed as discussed above. The transfercartridge 14 can then be disposed of or can be retained for additionaltesting procedures. In addition, bar code labels or RFID tags that canbe read by the centrifuge device 32 may be provided on the transfercartridge 14 to provide various information to the system.

Some of the advantages of the present disclosure over prior systems arethat it is a closed system which reduces sample exposure, it providespassive and fast mixing of the sample with an anti-coagulant, itfacilitates separation of the sample without transferring the sample,and it is capable of transferring pure plasma to the point-of-caretesting device 90.

The blood sampling transfer device of the present disclosure may also beused to transfer a blood sample to a point-of-care testing device thatuses the whole blood sample as an input. Not every application of theblood sampling transfer device of the present disclosure would requirethat plasma be created by centrifugation.

While this disclosure has been described as having exemplary designs,the present disclosure can be further modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses, or adaptations of the disclosure using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this disclosure pertains and which fallwithin the limits of the appended claims.

What is claimed is:
 1. A blood sampling transfer device, comprising: anadhesive lancing tape having a target, and a flow channel in fluidcommunication with a portion of the target; a transfer cartridgeremovably connected to the lancing tape, the transfer cartridge having areservoir, wherein the adhesive lancing tape and the transfer cartridgeare positioned in the same horizontal plane relative to one another, anda frangible portion integrally formed between the transfer cartridge andthe lancing tape such that the transfer cartridge and the lancing tapeare detachably connected to one another via the frangible portion, thefrangible portion including a sealing wall, the sealing wall configuredsuch that upon breaking of the frangible portion to remove the transfercartridge from the lancing tape, the sealing wall seals the reservoir,and wherein an inlet of the reservoir connected to the frangible portionis laterally offset from the target relative to a puncture direction ofa puncturing element into the target, wherein the flow channel isconfigured to permit a blood sample to flow from the target and throughthe frangible portion before entering the transfer cartridge, wherein,in a first position when the transfer cartridge is connected to thelancing tape, the reservoir is configured to be in fluid communicationwith the flow channel, and wherein, in a second position when thetransfer cartridge is disconnected from the lancing tape, the transfercartridge is configured to be separated from the lancing tape.
 2. Theblood sampling transfer device of claim 1, wherein the target of thelancing tape is aligned with the flow channel to promote flow of theblood sample via capillary action.
 3. The blood sampling transfer deviceof claim 1, wherein the target of the lancing tape is a circular graphicindicator.
 4. The blood sampling transfer device of claim 1, wherein thetransfer cartridge includes a transfer cartridge flow channel in fluidcommunication with the reservoir.
 5. The blood sampling transfer deviceof claim 4, wherein the transfer cartridge flow channel comprises asample stabilizer and the transfer cartridge flow channel is configuredto allow for passive mixing of the sample with the sample stabilizer. 6.The blood sampling transfer device of claim 4, wherein the transfercartridge includes a dispensing bulb in fluid communication with thetransfer cartridge flow channel, the transfer cartridge flow channeldisposed between the dispensing bulb and the reservoir.
 7. A bloodsampling system, comprising: a lancet device having a lancet; and ablood sampling transfer device, comprising: an adhesive lancing tapehaving a target, and a flow channel in fluid communication with aportion of the target; a transfer cartridge removably connected to thelancing tape, the transfer cartridge having a reservoir, wherein theadhesive lancing tape and the transfer cartridge are positioned in thesame horizontal plane relative to one another, and a frangible portionintegrally formed between the transfer cartridge and the lancing tapesuch that the transfer cartridge and the lancing tape are detachablyconnected to one another via the frangible portion, the frangibleportion including a sealing wall, the sealing configured such that uponbreaking of the frangible portion to remove the transfer cartridge fromthe lancing tape, the sealing wall seals the reservoir, and wherein aninlet of the reservoir connected to the frangible portion is laterallyoffset from the target relative to a puncture direction of the lancetinto the target, wherein the flow channel is configured to permit ablood sample to flow from the target and through the frangible portionbefore entering the transfer cartridge, wherein, in a first positionwhen the transfer cartridge is connected to the lancing tape, thereservoir is configured to be in fluid communication with the flowchannel, and wherein, in a second position when the transfer cartridgeis disconnected from the lancing tape, the transfer cartridge isconfigured to be separated from the lancing tape.
 8. The blood samplingsystem of claim 7, wherein the target of the lancing tape is a circulargraphic indicator.
 9. The blood sampling system of claim 7, wherein thetransfer cartridge includes a transfer cartridge flow channel in fluidcommunication with the reservoir to promote passive movement of theblood sample through the transfer cartridge flow channel via capillaryaction.
 10. The blood sampling system of claim 9, wherein the transfercartridge flow channel comprises a sample stabilizer and the transfercartridge flow channel is configured to allow for passive mixing of thesample with the sample stabilizer.
 11. The blood sampling system ofclaim 9, wherein the transfer cartridge includes a dispensing bulb influid communication with the transfer cartridge flow channel, thetransfer cartridge flow channel disposed between the dispensing bulb andthe reservoir.
 12. A blood sampling system, comprising: a lancet devicehaving a lancet; a blood sampling transfer device, comprising: anadhesive lancing tape having a target, and a flow channel in fluidcommunication with a portion of the target; a transfer cartridgeremovably connected to the lancing tape, the transfer cartridge having areservoir, wherein the adhesive lancing tape and the transfer cartridgeare positioned in the same horizontal plane relative to one another, anda frangible portion integrally formed between the transfer cartridge andthe lancing tape such that the transfer cartridge and the lancing tapeare detachably connected to one another via the frangible portion, thefrangible portion including a sealing wall, the sealing configured suchthat upon breaking of the frangible portion to remove the transfercartridge from the lancing tape, the sealing wall seals the reservoir,and wherein an inlet of the reservoir connected to the frangible portionis laterally offset from the target relative to a puncture direction ofthe lancet into the target, wherein the flow channel is configured topermit a blood sample to flow from the target and through the frangibleportion before entering the transfer cartridge, wherein, in a firstposition when the transfer cartridge is connected to the lancing tape,the reservoir is configured to be in fluid communication with the flowchannel, and wherein, in a second position when the transfer cartridgeis disconnected from the lancing tape, the transfer cartridge isconfigured to be separated from the lancing tape; and a packaging memberhaving a compartment sized and adapted to receive the lancet device andthe blood sampling transfer device therein.
 13. The blood samplingsystem of claim 12, wherein the lancing tape includes the adhesive on aninferior surface of the lancing tape.
 14. A blood separation system fora blood sample having a cellular portion and a plasma portion, the bloodseparation system comprising: a blood sampling transfer device adaptedto receive the blood sample, the blood sampling transfer devicecomprising: an adhesive lancing tape having a target, and a flow channelin fluid communication with a portion of the target; a transfercartridge removably connected to the lancing tape, the transfercartridge having a reservoir, wherein the adhesive lancing tape and thetransfer cartridge are positioned in the same horizontal plane relativeto one another, and a frangible portion integrally formed between thetransfer cartridge and the lancing tape such that the transfer cartridgeand the lancing tape are detachably connected to one another via thefrangible portion, the frangible portion including a sealing wall, thesealing wall configured such that upon breaking of the frangible portionto remove the transfer cartridge from the lancing tape, the sealing wallseals the reservoir, and wherein an inlet of the reservoir connected tothe frangible portion is laterally offset from the target relative to apuncture direction of a puncturing element into the target, wherein theflow channel is configured to permit a blood sample to flow from thetarget and through the frangible portion before entering the transfercartridge, wherein, in a first position when the transfer cartridge isconnected to the lancing tape, the reservoir is configured to be influid communication with the flow channel, and wherein, in a secondposition when the transfer cartridge is disconnected from the lancingtape, the transfer cartridge is configured to be separated from thelancing tape; and a centrifuge having a receiving port adapted toreceive the transfer cartridge, wherein with the transfer cartridgereceived within the centrifuge and a rotational force applied to thetransfer cartridge, the centrifuge is configured such that the plasmaportion of the blood sample is separated from the cellular portionthrough the reservoir.
 15. The blood separation system of claim 14,wherein the lancing tape includes the adhesive on an inferior surface ofthe lancing tape.